Conformity Assessment Documents Explained
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Australian Hazardous Area Certification Requirements
Hazardous area equipment certification schemes have been introduced as way of giving the end user or customer the assurance that the equipment they are buying meets the required industry standards and provides suitable protection against ignition. Without a standardised certification scheme in place it would be left to the end user to make individual assessments on the safety of equipment used in hazardous areas. This would require vast amounts of testing and validation by individuals and is obviously not practical. Currently there are multiple hazardous area safety directives and certification schemes running throughout the world, these include ATEX, FM Factory Mutual, UL Underwriters Laboratory and CSA Canadian Standards Association.
The hazardous area certification systems currently accepted in Australia are detailed in AS/NZS 60079.14:2017 clause 220.127.116.11. There are 3 schemes for hazardous area equipment that can be accepted under specific circumstances:
- The equipment has a current certificate under the IECEx or the ANZEx schemes.
- The equipment has a cancelled or suspended IECEx or ANZEx certificate and it can be demonstrated that the equipment was manufactured whilst the certificate was current.
- The equipment was issued with a certificate issued under the AUSEx Scheme and the equipment was manufactured within the certificate validity period.
The selection and use of equipment which has a certificate issued by a third party (ATEX, FM, UL or CSA) that does not meet the criteria listed above is restricted to circumstances where the use of equipment meeting the certification requirements above is not practical. There is plenty of debate about what is defined as “not practical” and ultimately the person(s) in control of the installation, or their nominee will need to be satisfied that the use of IECEx , ANZEx or AUSEx certified equipment was either not possible or not practical.
If the person(s) in control of the installation is satisfied that the use of IECEx, ANZEx or AUSEx certified equipment was either not possible or not practical and they wish to use a piece of equipment holding another certification (ATEX, FM, UL or CSA) they will need to justify the use of any alternative equipment used. In order to do this an assessment and justification of the equipment must be completed by a competent person. The justification must be included as part of the site hazardous area verification dossier. The justification is best demonstrated in the form of a Hazardous Area
Conformity Assessment Document CAD (refer to AS/NZS 60079.14:2017).
CAD Author Requirements
As mentioned previously the equipment assessment must be completed by a competent person, it is expected that the assessor of the CAD holds the ‘Conduct a Conformity Assessment of Explosion Protected Equipment’ units of competency in accordance with AS/NZS 4761.1 or an equivalent.
Conformity Assessments Documents (CAD)
A conformity assessment document commonly referred to as a CAD is a documented justification by a competent person that the equipment certified by an alternative third party (ATEX, FM, UL or CSA) not recognised in Australia has been certified to a system equivalent to, or better than an ISO/IEC 17067 Scheme type 5 and that the standards it was certified to offer an equivalent level of safety to the corresponding IEC or AS/NZS standards.
ISO/IEC 17067 Scheme type 5
The ISO/IEC 17067 Scheme type 5 is a scheme that requires an assessment of the equipment to be certified, as well as an assessment of the manufacturing and quality management systems associated with its production. The final critical element to the ISO/IEC 17067 Scheme type 5 is surveillance. There are two parts to this surveillance, firstly there is surveillance of the quality system and secondly there is surveillance of the equipment. Samples of the equipment may be taken from either the market or the point of production or both and may be assessed for ongoing conformity. The extent to which the three elements of ongoing surveillance are conducted can be adjusted for a given situation. As a result, this system provides significant flexibility for ongoing surveillance.
This Scheme type 5 certification system includes the following:
- Samples on request by the certification body.
- Evaluation of the Test Report.
- Initial conformity assessment of the quality system.
- Licence (Certificate of Conformity).
- Surveillance of the quality management system of the organization.
- Surveillance on equipment from the market.
As mentioned previously the author of the CAD is required to verify the equipment meets the requirements of a Scheme type 5 and they must also ensure the standards used for designing the equipment and testing offer an ‘equivalent level of safety’ to the corresponding IEC or AS/NZS standards. This will require a detailed assessment of the standards the equipment was built to against the corresponding IEC or AS/NZS standards. This is a complicated task that should only be undertaken by competent experts with a detailed understanding of hazardous area equipment and systems. This is because when a difference is the standards is detected, the conformity assessment document assessor must make a determination as to whether this difference or deviation in the standards will prevent the equipment from offering an ‘equivalent level of safety’ to the corresponding IEC or AS/NZS standards.
ATEX Conformity Assessments Documents CAD
The ATEX directives consists of two EU directives describing the minimum safety requirements of the workplace and equipment used in explosive atmosphere. The term ATEX derives its name from “Appareils destinés à être utilisés en ATmosphères EXplosives”
The ATEX directive covers all equipment that is intended for use in potentially explosive atmospheres that is to be placed on the EU market. Equipment covered by the ATEX directive is required to fulfill the essential health and safety requirements relating to the design and construction of equipment and protective systems. One way the manufacturer can assume that this is the case is if the equipment is designed and certified to harmonize with European Standards or Norms (EN). The European harmonised standard references are published in the Official Journal of the European Union (OJEU).
ATEX Equipment is Not Always Eligible for a CAD
There will be situations where the author of the Conformity Assessment Document (CAD) will find the equipment does not meet the requirements of a Scheme type 5 or the standards the equipment was built and tested to do not offer an equivalent level of safety to the corresponding IEC or AS/NZS standards. For instance, under the ATEX directive the issuing of an EC-Type Examination certificate for category 3 devices (zone 2 and 22) is not mandatory. The manufacturer will in this case issue a declaration in the form of an EC Certificate of Conformity the confirms the equipment meets the requirements of the ATEX directive and the harmonised standards. This does not represent suitable certification unless it is also supported by a certificate issued by an acceptable ExNB with the supporting test report.
Documentation Normally Required for an ATEX CAD
The following individual documents normally issued in accordance with the ATEX directive should be used as ‘objective evidence’ to support the findings and justification within the CAD. All of the supporting documents should be in English, if they are not, they will require a certified translation.
- EC-Type Examination Certificate issued by a registered Notified Body [ExNB]
- ‘Test Report’, ‘Assessment and Test Report’, ‘Confidential Report’ or similar
- EU Quality Production Notification, Production Quality Assurance Notification (PQAN)
- ISO 9001 Certification
- EU declaration of conformity (not essential)
Factory Mutual FM and Underwriters Laboratory UL Conformity Assessment Document (CAD)
Equipment the meets the Factory Mutual FM and Underwriters Laboratory UL certification programs can usually be assumed to meet the requirements of a scheme type 5 provided the certification is valid. Factory Mutual FM and Underwriters Laboratory UL conduct their own testing and have strict factory surveillance requirements. The CAD assessor must ensure that the certificate for the equipment under consideration is valid, the certificate will then identify the Standards used for the design and testing of the equipment and will allow a Conformity Assessment Document to be prepared. The big challenge for the assessor of an FM or UL CAD comes from the often-significant technical differences in the UL/FM standards to the equivalent IEC and AS/NZS 60079 standards. The Conformity Assessment Document should contain full information of any applicable variation to the requirements of the AS/NZS or IEC 60079 Standards.
Canadian Standards Association CSA Conformity Assessment Document (CAD)
Equipment the meets the Canadian Standards Association CSA certification programs can usually be assumed to meet the requirements of a scheme type 5 provided the certification is valid. The North American compulsory factory surveillance program is also applied in Canada. This means that the evidence of a Certificate of Compliance will identify the Standards used and allow a Conformity Assessment Document to be prepared. The assessor of a CSA CAD will face similar issues to the UL CADs and FM CADs in that there will often be significant technical differences in the CSA standards to the equivalent IEC and AS/NZS 60079 standards. The assessor will also need to verify that CSA has conducted all the testing or can accept the Test Report used under the terms of their accreditation. All of this should be clearly documented or referenced within the conformity assessment document.
Common Elements of a Hazardous Area Conformity Assessment Document CAD
The following items should be provided in the Conformity Assessment Documents before the person(s) in control of the insulation accept the CAD.
- Executive summary
- The equipment and application
- Equipment description
- Function of the product including proposed location
- Standards of conformity and assessment
- Training of installation and maintenance personnel
- Overhaul, installation, and maintenance requirements
- Authorization of report
- Attached supporting documents and certificates
“This following information represents and opinion only of a general nature, the specifics of each individual situation must be taken into account with reference to the relevant Legislation, Codes of practice and Australian standards. Professional advice should be sort if there is any doubt.”